The ORIP High-End Instrumentation Grant (HEI) program
encourages applications from groups of NIH-supported investigators to
purchase a single major item of equipment to be used for biomedical research
that costs at least $750,000. The maximum award is $2,000,000. Instruments in
this category include, but are not limited to, biomedical imaging systems,
NMR spectrometers, mass spectrometers, electron microscopes and
supercomputers.

Key Dates

Posted Date

February 1, 2013

Open Date (Earliest Submission Date)

August 13, 2013

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

September 13, 2013, by 5:00 PM local time of applicant
organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

January to February, 2014

Advisory Council Review

May, 2014

Earliest Start Date

July 1, 2014

Expiration Date

September 14, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH
Guide for Grants and Contracts). Conformance to all requirements (both
in the Application Guide and the FOA) is required and strictly enforced. Applicants
must read and follow all application instructions in the Application Guide as
well as any program-specific instructions noted in Section IV. When the program-specific
instructions deviate from those in the Application Guide, follow the
program-specific instructions. Applications that do not comply with
these instructions may be delayed or not accepted for review.

With advances in technological
development, biomedical scientists require ever more powerful tools for their
research. As new instruments with enhanced performance become available, their
importance for research increases along with the costs. Although the Shared
Instrumentation Grant Program (SIG) provides a cost effective mechanism for
groups of NIH supported investigators to obtain commercially available
equipment costing between $100,000 and $600,000, there is a continuing need for
an NIH program that provides expensive, high-end instruments to the broad
community of basic and clinical scientists. To meet this need, ORIP continues the HEI program
that was initiated in FY 2002 to support expensive, high-end instruments. The
focus of the HEI Program is on a new generation of instruments that cost over
$1,000,000 but the floor for the program has been set at $750,000. Applications
for routine instruments such as midfield NMR spectrometers or other
applications for requests totaling over $750,000 which are the result of an
over-estimation of price and/or an excessive number of accessories, are not
appropriate.

Applicants may also propose an Integrated Instrument system
in which the components, when used in conjunction with one another, perform a superior
or innovative function that no single component instrument could provide for
the user group. The integrated components must be dedicated to the system and
not used independently. Increase in productivity or efficiency is not
sufficient justification for an integrated system. The Integrated Instrument
cannot require research and development but may include minor adaptations, as
needed, to connect commercially available instruments and components. Applicants
must contact HEI scientific program officials (See Section VII) prior to
submitting an application for an Integrated Instrument system and must obtain a
letter of permission from program staff to be included in the HEI application.
Instruments must be for research purposes only. Foreign made equipment is
allowable.

Examples of HEI instruments include, but are not limited to:

Biomedical Imagers: Cutting-edge medical imaging technologies and
novel data processing algorithms have allowed the visualization of structures
and metabolic/molecular activities on intact biological systems including
humans. Examples of imagers may include MRI, CT, PET, SPECT as well as
co-modalities.

Ultrahigh-Field Nuclear Magnetic Resonance Spectrometers: There
is a significant demand for ultrahigh-field NMR spectrometers for enhanced
sensitivity and increased resolution to determine three-dimensional structures
of large proteins and protein complexes in extremely small samples. This need
is magnified by the extended run time for data collection at lower fields,
which limits access to these instruments.

Mass Spectrometers: Instruments that combine electrospray
ionization with Fourier transform ion cyclotron resonance (FTICR) mass
spectrometry are now available. The FTICR methods provide very high resolution
and accurate molecular weight measurement to study large biopolymers and their
interactions.

Electron Microscopes: The frontier of cell biology now focuses on
elucidating the nature and function of cell organelles and the role of complex
protein machines. Such studies require intermediate voltage electron
microscopes with field emission illumination for high resolution imaging of
single molecules. Such microscopes are also needed to perform computer
reconstruction at the subnanometer scale for macromolecular assemblies that are
too large and complex to study by x-ray crystallography and NMR spectroscopy.

Supercomputers: Computational biologists require high performance
computers or clusters of computers for large-scale data processing, storage and
transfer. Applications for general use computer networks will not be accepted.

Applications for synchrotron equipment, with the exception
of detectors, are not appropriate for this FOA.

The HEI program will not support requests for:

the development of new instrumentation;

general purpose equipment or purely instructional equipment;

instruments used for clinical (billable) care;

an instrument with a base cost of less than $750,000;

multiple instruments bundled together to meet the $750,000
minimum;

a series of complementary related instruments which share a
common research focus;

an assortment of instruments to furnish a research facility;

software unless it is integral to the operation of a piece of
equipment;

For eligibility, a major user group of three or more
investigators who are PDs/PIs on active NIH research grants with the following
activity codes, P01, R01, U01, R35, R37, DP1 and DP2 must be identified. Once
this eligibility requirement has been met, additional users with other types of
active NIH research grants (such as but not limited to R00, R03, R21, P30, P41,
P50) mechanisms) can be added as major or minor users. NIH training grants and
contracts are not eligible. To demonstrate the clear need for the requested
instrumentation, projects supported by NIH research grants should require at
least 75 percent of the total usage time.

Major users can be individual researchers, or a group of
investigators within the same department or from several departments at the
applicant institution. NIH extramural awardees from other nearby institutions
may also be included.

If the major user group does not require total usage of the
instrument, access to the instrument should be made available to other users
upon the advice of the internal advisory committee (see below). These users
need not be NIH awardees, but priority should be given to NIH-supported
scientists engaged in biomedical/behavioral research.

It is expected that some of the equipment requested under
the HEI Program will be of a specialized nature and will require a high level
of technical expertise to operate the instrument and conduct experiments.
Therefore, for the requested instrument to be used effectively and to avoid
abuse of the instrument, which frequently occurs in an open access environment,
the bulk of the research time may have to be reserved for a few investigators.
Alternatively, some type of instruments might be accessed by the research
community through collaborations with appropriate investigators. Other types of
instruments requested may not be so dedicated; such instruments will serve a
broadly diversified biomedical community and should be located within a central
core facility.

Each applicant institution must propose a PD/PI who can
assume administrative/scientific oversight responsibility for the
instrumentation requested. This person need not be an NIH grantee but must be
affiliated with the applicant institution. An internal advisory committee must
be named to assist the PD/PI in administering the grant and overseeing the
usage of the instrument. The committee should include members with diverse
expertise. The PD/PI and the advisory committee are responsible for:

Maximum utilization of the instrument, including time allocation.

A detailed plan for the day-to-day management and safe operation
of the instrument.

If appropriate, a plan to ensure that access to the instrument is
limited to users whose projects have received approval by institutional human
subjects, animal welfare or biosafety committees.

A financial plan for the long term operation and maintenance of
the instrument during the post award period.

Considering and recommending to the NIH the relocation of the
instrument within or outside the institution, if such relocation is necessary
See Section VI.1.

Review of the Annual Equipment Usage Report.

The PD/PI also will be responsible for:

Requesting no-cost extensions of the project period, if needed.

Submitting a Final Progress Report, ninety days following the end
of the project period, which describes the instrument purchased, a list of all
users and publications resulting from use of the instrument, and a description
of the value of the instrument to the investigators and to the institution as a
whole. See Section VI.3.

Submitting annual equipment usage reports to the NIH for a period
of four years after the final progress report. See Section
VI.3.

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or
both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Resubmission

The OER
Glossary and the SF424 (R&R) Application Guide provide details on
these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations
and the submission of a sufficient number of meritorious applications.

ORIP intends to fund an estimate of 10-15 awards,
corresponding to a total of $20 million, for fiscal year 2014. Since the cost
of the various instruments will vary, it is anticipated that the size of the
award also will vary. The total amount awarded and the number of awards will
depend on the funds available for the HEI program.

Award Budget

Applications will be accepted that request a single,
commercially available instrument or integrated system which costs at least
$750,000. There is no upper limit on the cost of the instrument, but the
maximum award is $2,000,000.

Award Project Period

The project period is limited to one year.

NIH grants policies as
described in the NIH Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Under the general research support authority of Section
301(a) (3) of the Public Health Service Act, High End Instrumentation Grant
awards are made to public and non-profit domestic institutions only. These
institutions include health professional schools, other academic institutions,
hospitals, health departments, and research organizations. Note that
Federal institutions, foreign institutions and for-profit institutions are not
eligible to apply. A Federal institution is defined by the NIH as a
Cabinet-level department or independent agency of the executive branch of the
Federal Government or any component organization of such a department or
agency. Foreign (non-U.S.) components of U.S. Organizations are not allowed.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Applicant organizations must complete the following registrations
as described in the SF424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.

System for
Award Management (SAM)– must maintain an active entity registration
(formerly CCR registration), to be renewed at least annually. Use the Sam.gov
“Manage Entity” function to manage your entity registrations. See the Grants
Registration User Guide at SAM.gov for additional information.

All Program Directors/Principal Investigators (PD(s)/PI(s))
must also work with their institutional officials to register with the eRA
Commons or ensure their existing eRA Commons account is affiliated with the eRA
Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Applicant organizations may submit more than one application,
provided that each application is for a different instrument.

NIH will not accept any application that is essentially the
same as one already reviewed within the past thirty-seven months (as described
in the NIH
Grants Policy Statement), except for submission:

To an RFA of an application that was submitted previously as an
investigator-initiated application but not paid;

Of an investigator-initiated application that was originally
submitted to an RFA but not paid; or

Of an application with a changed grant activity code.

Determination
of New Application Status: A new application is expected to be
substantially different in content and scope with more significant differences
than are normally encountered in a resubmitted application. For S10
applications, there must be a substantial change in more than one critical
aspect of the application, which may include a change in the composition of
major or minor users due to a change in instrumentation needs or NIH grant
support, inclusion of new preliminary data for several users, specific documented
changes in institutional commitment or changes in technical expertise and the
administrative/management structure.

Major Users

For eligibility, a major user group of three or more
investigators who are PDs/PIs on active NIH research grants with the following
activity codes, P01, R01, U01, R35, R37, DP1 and DP2 must be identified. Once
this eligibility requirement has been met, additional users with other types of
active NIH research grants (such as but not limited to R00, R03, R21, P30, P41,
P50 mechanisms) can be added as major or minor users. NIH training grants and
contracts are not eligible. To demonstrate the clear need for the requested
instrumentation, projects supported by NIH research grants should require at
least 75 percent of the total usage time.

Major users can be individual researchers, or a group of
investigators within the same department or from several departments at the
applicant institution. NIH extramural awardees from other nearby institutions
may also be included.

Section IV. Application and Submission Information

1. Requesting an
Application Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

The forms package associated with this FOA includes all
applicable components, mandatory and optional. Please note that some
components marked optional in the application package are required for
submission of applications for this FOA. Follow all instructions in the SF424
(R&R) Application Guide to ensure you complete all appropriate “optional”
components.

Page Limitations

All page limitations described in the SF424 Application
Guide and the Table of
Page Limits must be followed, with the following exception:

For this FOA, there is no overall page limit for the entire
Instrumentation Plan. However, there are specified page limitations for each
section of the Instrumentation Plan as described below. The sections cannot
exceed the page limit including tables, graphs, figures, diagrams, and charts.
Although there is no overall page limit, applicants are reminded to be
informative yet succinct.

Introduction:
3 pages

Justification
of Need: 6 Pages

Research
Projects:

Major Users: 6 pages
per user (recommend no more than 3 pages)

Minor Users: 6 pages
in total for the research related to the need for the requested instrument.

Summary
Table(s): 6 pages in total

Combined Technical
Expertise and Administration of the Instrument: 6 pages in
total

Combined Institutional
Commitment and Overall
Benefit: 6 pages in total

Note: Letters of Support are not included in the page
limitations.

Special
Application Instructions for this FOA

Below are special instructions for this FOA describing the
information that must be included in the required components of the
application.

SF424(R&R) Cover Component

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions.

Descriptive
Title

Enter the generic name of the instrument requested in the
title (for example, 600MHz NMR Spectrometer).

Proposed
Project

Enter start date of 07/01/2014 and end date of 06/30/2015.

Estimated
Project Funding

Total Federal Funds Requested. Enter the total Federal funds
for the requested instrument. This will be the total cost since the award
period for the HEI program is one year. If the cost of the instrument is more
than $2 million enter $2 million on this line, since this is the maximum award
under the HEI program.

Total Non-Federal Funds. If Total Federal Funds Requested
(described immediately above) and Total Federal & Non-Federal Funds
(described immediately below) are not the same, enter the difference. Explain
how the difference will be paid in the Equipment section on the SF424 (R&R)
Other Project Information component (described below).

Total Federal & Non-Federal Funds. Enter the total cost
of the instrument from the quote.

Estimated Program Income. Enter zero as Program Income does
not apply to the HEI Program.

** NOTE: A warning will be generated during submission for
any S10 with a budget in excess of $500,000. This warning can be ignored.

SF424 (R&R) Other Project Information Component

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions.

Note that Human Subjects are not involved and Vertebrate
Animals are not used. Both should be checked "No".

Project
Summary/Abstract

The Project Summary/Abstract is meant to serve as a succinct
and accurate description of the proposed work when disassociated from the
application. State the application’s broad, long-term objectives and specific
aims, making reference to the health relatedness of the project. Describe
concisely the research design and methods for achieving the stated goals. This
section should be informative to other persons working in the same or related
fields and understandable to a scientifically or technically literate reader.

NOTE: The Project Summary/Abstract must be no longer than 30
lines of text.

Project
Narrative

Using no more than two or three sentences, describe the
relevance of this research to public health. In this section be succinct and
use plain language that can be understood by a general, lay audience.

Bibliography
& References Cited

Each major user should list only those publications that
demonstrate the user's expertise in using the requested instrumentation.

Facilities
& Other Resources

Not applicable. Do not include an attachment here.

Equipment

Describe the instrument requested including manufacturer and
model number. The model chosen should be justified by comparing its performance
with other available instruments where appropriate. Specific features and any
accessories should be justified, both in this section and in the description of
research projects. Such accessories must be utilized by at least half of the
users. Provide a detailed budget breakdown of the main equipment and
accessories requested including tax and import duties, if applicable. An
itemized quote, with appropriate discount from a vendor is required. The quote
must be scanned and combined in a single attachment with the equipment
description as part of this upload. Applications
without itemized quote(s) will not be reviewed. As
described above in SF424 Cover Component, include an explanation of Total
Non-Federal Funds in this section (if applicable). If human or infectious
materials, which could create a potential biohazard, are to be analyzed, funds
for accessory containment equipment for the instrument may be requested in the
budget. In this case, a signed letter from the institutional biosafety
committee stating that they have reviewed the proposed containment plan and
that the plan adheres to documented biosafety regulations is required in the
application, and must be scanned and uploaded in the Other Attachments (described
immediately below).

Other
Attachments

Instrumentation
Plan (in lieu of Research Plan section). The entire Instrumentation Plan (with the sections described below) must be saved as a single file (named
Instrumentation Plan) and attached via the Other Attachments. Organize the
Instrumentation Plan in the specified order (described below) starting each
section with the appropriate section heading (i.e. Justification of Need,
Research Projects etc.). Do not include links to websites for further information.
Do not include animations.

Introduction: In the case of a resubmission, include an Introduction describing the changes
that have been made in response to comments in the previous review.

Justification
of Need: Describe the instrument requested. Provide an
inventory of similar instruments existing at the applicant institution,
neighboring research institutions, or otherwise accessible; describe why they
are unavailable or inappropriate for the proposed research. Provide a clear
justification for why new or updated equipment, including accessories, are
needed. Include specific documentation on the current usage and downtime of
existing instruments and a realistic estimate of the projected usage for the
requested instrument. Such documentation should be expressed as hours of use,
setup time, etc., per day or week, not simply as percentage of available time.
Be specific and quantitative; define available usage time. If proposing an Integrated Instrument,
additional detailed justification is required to explain how the integrated instrument
will provide unique functional capabilities for the user group that are not
available in any single available commercial instrument. Systems requiring
research and development are not acceptable other than adaptations to allow
connection of commercially available instruments and components.

Technical
Expertise: Describe the technical expertise present at the
institution to set up, run and maintain the instrument. Specify who will
operate the instrument, train new users, ensure that it is operated safely and
appropriately maintained.

Research
Projects:

Major Users: Major users are Program Director(s)/Principal Investigator(s) of active
NIH grants that require the use of the instrument and are identified by one of
these activity codes: P01, R01, U01, R35, R37, DP1 or DP2. Give a brief
description of the major users projects. Since the projects have been
previously peer reviewed, the project descriptions should be concise and focus
on the benefit of the instrument to the research objectives of each user.
Sufficient technical detail (preliminary data and/or supplemental information)
should be included to evaluate whether the instrument is appropriate, would be
effectively employed, and would provide advantages over other methods. If there
are a large number of major users, select a representative group (8-10) and
describe their research projects. The research project descriptions should be
informative and succinct.

Minor Users: Minor
users are additional users with other types of active NIH research grants (such
as but not limited to R00, R03, R21, R55, P30, P41, P50). NIH training grants
and contracts are not eligible. For minor users, only include a very brief
summary of the research related to the need for the requested instrument.

Special Features and Accessories: Requests for special features and accessories for the proposed instrument must
be justified. Users with individual projects that require a specific option or
upgrade (e.g., an additional UV laser) should describe the specific studies
that require this option. At least half of the major users should need the requested
special feature options or accessories for the proposed instrument.

Integrated Instrument: If proposing an integrated instrument, users must specifically justify the need
for the integrated instrument in their research.

Summary
Table(s): Use a table to list the names (last, first) of the
major and minor users from the Research Projects section, the complete NIH
grant numbers (e.g. 5R01HL123451-01A1), brief titles of the projects and the
estimated percentage of use. Make a separate table to indicate the users’
needs for any requested accessories.

Administration
of the Instrument

Organizational / Management Plan: Describe the organizational plan to administer the grant. Include how the
instrument will be utilized, how requests will be made, how time will be
allocated among major and minor users and plans for attracting new users. An
internal advisory committee must be named to assist the PD/PI in administering
the grant and overseeing the usage of the instrument. The committee should
include members with diverse expertise. List the names and titles of the
members of the local advisory committee. Describe a plan for managing access to
the instrument if users’ projects involve human subjects, animals or human of
infectious materials.

Financial Plan: Submit
a specific financial plan for long-term operation and maintenance of the
instrument. Pertinent data on user charges, salaries of technical support
personnel, maintenance contracts, instrument upgrades, shop charges and other
expenses should be included. Specify the sources and amounts of additional
needed funds (private, state or institutional funds) and a projection of when
they will be available. Give a time frame or prospects for delivery of the
instrument.

Institutional
Commitment: An appropriate level of institutional support to
ensure associated infrastructure sustainment is required. Institutional
Commitment to the specific financial plan for operation and maintenance of the
instrument may include, but is not limited to, support of maintenance
contracts, preparation and maintenance of the installation site, contribution
to the costs of the operating staff, and any other financial contribution towards
the support and acquisition of the instrument. Describe the institutional
infrastructure available to support the instrumentation. Provide documentation
(e.g., separate letters of support signed by appropriate institutional
officials must also be included in the Letters of Support section) specifically
describing the required institutional commitment (in dollars) in support of the
proposed financial plan. Those letters must be named “Letters of Support” and
uploaded as a separate file in the Other Attachments (described below).

Overall
Benefit: Explain how the instrument will impact NIH-funded
research and contribute to the institution’s long- range biomedical research
goals.

Letters
of Support. Letters of support from institutional officials
confirming specific dollar and other support commitments ( that are described
in detail in the section on Institutional Commitment) and any letters from the
biosafety committee (as described in Equipment) should be combined in a single
file named Letters of Support and uploaded as a separate attachment via Other
Attachments.

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Each applicant institution must propose a PD/PI who can
assume administrative/scientific oversight responsibility for the
instrumentation requested. This person need not be an NIH grantee but must be
affiliated with the applicant institution.

Major users can be individual researchers, or a group of investigators
within the same department or from several departments at the applicant
institution. NIH extramural awardees from other nearby institutions may also be
included.

Include profiles for the Program Director(s)/Principal
Investigator(s), the Major Users, and for the technical person(s) responsible
for the maintenance and operation of the instrument. For the Major Users,
select “Other” under Project Role. Then complete the Other Project Role
Category by inserting Major User. For technical person(s), select “Technician”
for Project Role field. Follow the instructions in the SF424 (R&R)
Application Guide for Additional Senior/Key Person Profile(s) if there are more
than 8 major users.

NOTE: Current
and Pending Support. Since Just-in-Time does not apply to the
S10 mechanism, this FOA requires current and pending support for the Program
Director(s)/Principal Investigator(s), each major user and/or technician at the
time of application submission. Follow the format provided in Other Support
section of the SF424 (R&R) Application Guide (Part III. Section 1.8. Other
Support.)

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

The Research
Plan component is not required in this FOA. However, an Instrumentation Plan must be uploaded via Other Attachments (see above for details).

Resource Sharing Plan

Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide, with the following modification:

Generally, Resource Sharing Plans (Data Sharing Plan, Sharing
Model Organisms, and GWAS Sharing Plan) are expected, but they are not
applicable for this FOA.

Appendix

Do not use the Appendix to circumvent page limits. Follow
all instructions for the Appendix as described in the SF424 (R&R)
Application Guide, with the following modification:

Do not place any required information in the Appendix.

3. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications
before the deadline to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants
across all Federal agencies. Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.

Applicants
are responsible for viewing their application before the deadline in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

Under the S10 mechanism, funding requests are limited to the
purchase cost of the instrument only. Support for technical personnel, service
contracts, extended warranties, and supplies are not allowable. Cost sharing
towards purchase of the instrument is not required. If the amount of funds
requested does not cover the total cost of the instrument, the application should
describe the proposed source(s) of funding for the balance of the cost of the
instrument. Documentation of the availability of the remainder of funding,
signed by an appropriate institutional official, must be presented to ORIP
prior to issuance of award.

The program does not provide facilities and administrative
(F&A) costs or support for construction or alterations or renovations.
Matching funds are not required. However, commitment of an appropriate level of
institutional support to ensure the associated sustaining infrastructure is
expected and should be described. Appropriate Grants will be awarded for a
period of one year and are not renewable. Supplemental applications will not be
accepted.

Applicants proposing purchase of an instrument that the
institution is planning to lease prior to award are urged to consult with their
institutional sponsored projects office regarding applicable NIH policy prior
to executing the leasing agreement. If the leasing agreement was executed more
than one year prior to submission of the HEI application, the applicant must
provide strong justification for the requested Federal funds. This
justification must demonstrate that the leased instrument is considered
state-of-the-art at the time of submission — appropriate award adjustments may
be necessary. Execution of a purchase order or agreement, making a down payment
or other formal commitment to purchase the equipment prior to award will
automatically eliminate an applicant from eligibility for an award.

6. Other Submission
Requirements and Information

Applications must be submitted electronically following the
instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.

Important
reminders:All PD(s)/PI(s) must include their eRA Commons ID in the
Credential fieldof the Senior/Key Person Profile Component of the
SF424(R&R) Application Package. Failure to register in the Commons
and to include a valid PD/PI Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management (SAM). Additional information
may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review, NIH. Applications that are
incomplete will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the project to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Justification of Need

Is the need for the instrument clearly and adequately
justified? Is the equipment essential and appropriate? Justification of
selection of proposed instrument may include but is not limited to comparison
with other available instruments of similar function. If the applicant is
requesting an Integrated
Instrument, is the request justified by superior results, as
compared to a single commercially available instrument, that is necessary to satisfy
the needs of the user group?.

Technical Expertise

Does the institution have the technical expertise to
make effective use of the requested equipment? How well qualified are the
participating investigators or other assigned personnel to operate and maintain
the instrument, conduct the projects, and evaluate the research results? How
will new users be trained? How will biosafety procedures be implemented?

Research Projects

Will research with the requested instrument advance
the knowledge and understanding of the proposed projects? How will the research
project of each major user be enhanced?

Administration

Is the plan for the management and maintenance of the
requested instrument appropriate? Are there plans for maximizing the effectiveness
of the investment in instrumentation? Is the membership of the advisory
committee broadly based to oversee the use of the instrument for a wide range
of biomedical investigators? How will research time be allocated among the
projects? Are the sharing arrangements equitable? If needed, are the policies
to manage human subject, animal or biohazardous materials projects adequate? Is
the Financial Plan for long term operation and maintenance of the instrument
reasonable?

Institutional Commitment

Is the institutional commitment for continued support
of the utilization and maintenance commensurate with the level of
sophistication of the requested instrument? Institutional Commitment to the
specific financial plan for operation and maintenance of the instrument may
include, but is not limited to, support of maintenance contracts, preparation
and maintenance of the installation site, contribution to the costs of the
operating staff, and any other financial contribution towards the support and
acquisition of the instrument. Is institutional infrastructure (technical
support, space, environment and utilities) adequate to support the instrument?
Is there an institutional track record for making technology available? Is
there appropriate documentation (letters from institutional officials)?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give
separate scores for these items.

Protections for Human Subjects

Generally not applicable. Reviewers should bring any
concerns to the attention of the Scientific Review Officer.

Inclusion of Women, Minorities, and
Children

Generally not applicable. Reviewers should bring any
concerns to the attention of the Scientific Review Officer.

Vertebrate Animals

Generally not applicable. Reviewers should bring any
concerns to the attention of the Scientific Review Officer.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the
application as now presented, taking into consideration the responses to
comments from the previous scientific review group and changes made to the
project.

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.

Applications from Foreign
Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Not Applicable

Budget and Period of Support

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s), convened by the Center for Scientific Review, in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit will be discussed and
assigned overall impact scores.

Will receive a written critique.

Applications will be assigned to the appropriate NIH
Institute or Center. Applications will compete for available funds with all
other recommended applications. Following initial peer review, recommended applications
will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding
decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

Program balance among various types of instruments supported and
geographic distribution of awards.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

A formal notification in the form of a Notice of Award (NoA)
will be provided to the applicant organization for successful applications. The
NoA signed by the grants management officer is the authorizing document and
will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any costs
incurred before receipt of the NoA are at the recipient's risk. These costs may
be reimbursed only to the extent considered allowable pre-award costs.

Ninety days after the expiration of the grant, a Final
Progress Report is required that describes the instrument purchased, and a list
of all users and description of the value of the instrument to the
investigators and to the institution as a whole. This report is needed by the
NIH for informing the public, administrative and Congressional officials about
the research resources it supports. The following information must be included
in the HEI Final Progress Report:

1. Information about the award and the instrument:

Grant Number: 1S10OD#####-01

Principal Investigator: (Name, Institution,
Department, Address)

Funding Period

Name of Instrument (including manufacturer and model)

Total Purchase Cost

Total HEI Award Amount

Other Sources of Funding (if appropriate)

2. Describe the HEI instrument purchased, its usage and its
impact on the research community, specifically the NIH funded users. Use a
summary table to list the names of the current major users (last, first), the
complete NIH grant numbers (e.g. 5R01HL123456-01A1), brief titles of the
projects and the percentage of use.

3. Describe the administration, operation, and plans for the
maintenance of the instrument.

4. Describe (in language understandable to the lay public)
any research accomplishments resulting from the use of the instrumentation.
Explain the developments in terms of their contributions to new knowledge and
potential for the improvement of human health. Provide a list of publications,
if available. Any publications on your final progress report should be
consistent with the NIH public access policy (http://publicaccess.nih.gov).

5. Include any other additional information which you would
consider useful to the NIH.

The HEI Final Progress Report must be submitted
electronically through the Closeout feature in eRA Commons.

Annual
Equipment Usage Report

In addition, for the period of four years after the final
progress report, annual equipment usage reports must be provided to the NIH.
The annual equipment usage reports must include:

1. The equipment usage records, specifically the name of the
user; number of hours used per year; and the active supporting NIH grants of the
user.

2. Machine downtime and explanation of any remediation
plans.

3. Any changes in administrative and technical operation of
the equipment from originally described in the application.

4. A list of publications and other research reports
depending, in part, on use of the awarded instrument. The publication list
should be consistent with the NIH Public
Access Policy.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH
Grants Policy Statement for additional information on this reporting
requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.